Evidence map›Paper›PMID 34607609›Full record

ArticleGenome medicine2021

Molecular profiling of advanced malignancies guides first-line N-of-1 treatments in the I-PREDICT treatment-naïve study.

Jason K Sicklick, Shumei Kato, Ryosuke Okamura, Hitendra Patel, Mina Nikanjam, Paul T Fanta, Michael E Hahn, Pradip De, Casey Williams, Jessica Guido and 9 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Genome medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 63 papers.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed
5.7field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02534675 completednot on this map

An Open Label Navigational Investigation of Molecular Profile-Related Evidence Determining Individualized Cancer Therapy for Patients With Incurable Malignancies and Poor Prognosis

TypeobservationalSponsorUniversity of California, San DiegoRan2015 to 2022Enrolled506ConditionsCancer
NCT07346209 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

STudy of Real-world Individualized Precision-oncology

TypeinterventionalSponsorUniversity of California, San DiegoRan2026 to 2031Enrolled280ConditionsMetastatic Cancer, Unresectable CarcinomaArmsMolecularly matched therapy, Standard of care
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 85 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Further Promise and Potential for Precision Medicine in Oncology.Journal of medical Internet research · 2026
    Article
  5. Review
  6. Observational
  7. Review
  8. Article
  9. Review
  10. Article
  11. Tumour-agnostic kinase inhibitors.Nature reviews. Drug discovery · 2025
    Review
  12. PersonalizedJCO precision oncology · 2025
    Observational
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Successful Targeting of SomaticJournal of immunotherapy and precision oncology · 2024
    Article
  20. Article

3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 5 institutions in 1 country.

Jason K SicklickDepartment of Surgery, Division of Surgical Oncology, UC San Diego School of Medicine, San Diego, CA, USA. jsicklick@health.ucsd.edu.ORCID 0000-0003-4403-0271
Shumei KatoCenter for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA.
Ryosuke OkamuraCenter for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA.
Hitendra PatelCenter for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA.
Mina NikanjamCenter for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA.
Paul T FantaCenter for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA.
Michael E HahnDepartment of Radiology, UC San Diego School of Medicine, San Diego, CA, USA.
Pradip DeAvera Cancer Institute, Sioux Falls, SD, USA.
Casey WilliamsAvera Cancer Institute, Sioux Falls, SD, USA.
Jessica GuidoCenter for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA.
Benjamin M SolomonAvera Cancer Institute, Sioux Falls, SD, USA.
Rana R McKayCenter for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA.
Amy KrieAvera Cancer Institute, Sioux Falls, SD, USA.
Sarah G BolesCenter for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA.
Jeffrey S RossFoundation Medicine, Inc., Cambridge, MA, USA.
J Jack LeeDepartment of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Brian Leyland-JonesAvera Cancer Institute, Sioux Falls, SD, USA.
Scott M Lippman *Center for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA.
Razelle Kurzrock *Center for Personalized Cancer Therapy, Moores Cancer Center, UC San Diego Health, 3855 Health Sciences Drive, Mail Code 0658, La Jolla, CA, 92093-0658, USA. rkurzrock@health.ucsd.edu.
UC San Diego Health System · USAvera Health · USSUNY Upstate Medical University · USThe University of Texas MD Anderson Cancer Center · USUniversity of California San Diego · US

Funding

VIRAL MALIGNANCYP30CA023100 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Jesse Nodora · 1985 to 2026
$124.9M
Targeting Drug-Resistant Cancer Stem Cell Niches of Gastrointestinal Stromal TumorR01CA226803 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SICKLICK, JASON KEITH · 2019 to 2023
$2.1M
Investigation of DNA Damaging Agents in GIST with Metabolic DysfunctionR01FD006334 · FDA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI SICKLICK, JASON KEITH · 2019 to 2021
$1.5M
FDA HHS R01 FD006334NCI NIH HHS P30 CA023100NCI NIH HHS R01 CA226803
6 · The paper itself

Abstract

backgroundMalignancies are molecularly complex and become more resistant with each line of therapy. We hypothesized that offering matched, individualized combination therapies to patients with treatment-naïve, advanced cancers would be feasible and efficacious. Patients with newly diagnosed unresectable/metastatic, poor-prognosis cancers were enrolled in a cross-institutional prospective study.

methodsA total of 145 patients were included in the study. Genomic profiling (tissue and/or circulating tumor DNA) was performed in all patients, and PD-L1 immunohistochemistry, tumor mutational burden, and microsatellite status assessment were performed in a subset of patients. We evaluated safety and outcomes: disease-control rate (stable disease for ≥ 6 months or partial or complete response), progression-free survival (PFS), and overall survival (OS).

resultsSeventy-six of 145 patients (52%) were treated, most commonly for non-colorectal gastrointestinal cancers, carcinomas of unknown primary, and hepatobiliary malignancies (53% women; median age, 63 years). The median number of deleterious genomic alterations per patient was 5 (range, 0-15). Fifty-four treated patients (71%) received ≥ 1 molecularly matched therapy, demonstrating the feasibility of administering molecularly matched therapy. The Matching Score, which reflects the percentage of targeted alterations, correlated linearly with progression-free survival (R

conclusionsPersonalized combination therapies targeting a majority of a patient's molecular alterations have antitumor activity as first-line treatment. These findings underscore the feasibility and importance of using tailored N-of-1 combination therapies early in the course of lethal malignancies.

trial registrationI-PREDICT ( NCT02534675 ) was registered on August 25, 2015.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyFemaleGenomicsHumansMaleMiddle AgedMolecular Targeted TherapyNeoplasmsProspective StudiesYoung AdultClinical trialGenomicsImmunotherapyPersonalizedPrecisionTargeted

Identifiers

PMID34607609
PMCPMC8491393
OpenAlexW3203792331

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.